Frequently Asked Questions

The Basics

What does "IRB" stand for?

What does the IRB oversee?

The IRB oversees human subjects research. Both components (“human subjects” and “research”) have to be met for the IRB to oversee it.

What are the definitions of "human subjects" and "research"?

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

(1) Data through intervention or interaction with the individual, or

(2) Identifiable private information.

Note that if your proposed research activity involves a drug, device, or biologic, other regulations and definitions may apply. Please contact the IRB for further clarification.

Can a student conduct human subjects research?

Yes, the regulations directly address that students can be investigators in human subjects research. However, all student-led research must have a faculty member identified as the principal investigator on their research application. The individual designated as PI must be eligible to serve as a PI at Princeton. Please see the PI eligibility criteria here.

Can my activities done as part of an internship, summer work, junior project, or senior thesis constitute human subjects research?

Yes, any of these activities may constitute human subjects research.

Examples

Is it possible to conduct human subjects research without any interaction with individuals?

Yes, if you will obtain, use, study, analyze, or generate identifiable private information or identifiable biospecimens for research purposes. Definitions of these key terms follow:

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public ( e.g., a tax record, educational record, or medical record).

Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. Examples of identifiers include names, social security numbers, medical record numbers, OR any code that permits the data to be linked to individually identifiable living individuals.

An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

My activity consists solely of data analysis. The data is neither private nor identifiable, based upon the above definitions. Is the activity human subjects research?

No. The data analysis is not human subjects research. Princeton IRB approval is not applicable.

My activity consists solely of data analysis. The data is private but not identifiable, based upon the above definitions. Is the activity human subjects research?

No. The data analysis is not human subjects research. Princeton IRB approval is not applicable.

My activity consists solely of data analysis. The data is identifiable but not private, based upon the above definitions. Is the activity human subjects research?

No. The data analysis is not human subjects research. Princeton IRB approval is not applicable.

Is it possible to conduct human subjects research without the recording of private identifiable information?

Yes, even if you are not recording private identifiable information, if you are obtaining it for research purposes, the activity is human subjects research.

If I’m interacting with individuals and obtaining data from them, but the data is not private and identifiable, does this mean I’m not doing human subjects research?

If you’re obtaining data through intervention or interaction with an individual for research purposes, the activity is human subjects research, though the data is not private and identifiable.

If I’m interacting with individuals and obtaining data from them, and the data is private and identifiable, does this mean I’m doing human subjects research?

Not necessarily. The activity may not be human subjects research because the knowledge from your systematic investigation may not be designed to be generalizable (widely applicable).

Example: If you are interacting with individuals to improve Princeton University, the activity may not be designed to develop or contribute to widely applicable knowledge.

Example: If you are interacting with individuals to learn about the history of Princeton University, the activity may not be designed to develop or contribute to widely applicable knowledge.

The IRB Review Process

Where are the IRB forms?

With the exception of the consent form template, you will upload forms as part of the eRIA submission process. Please see the eRIA SITE for more information.

What are the components of a new study submission?

A new study submission consists of the following:

Initial review application: The individual designated as PI must be eligible to serve as a PI at Princeton. Please see the PI eligibility criteria HERE.

Note that the IRB will verify that the PI and all Princeton research personnel have completed human subjects training. This is a one-time training requirement. The training can be from any source if the training directly addresses human subjects research. For example, training in conflicts of interest, biosafety, animal research, or responsible conduct of research work will not be recognized. Please see pages 5-6 of Princeton University IRB SOP 202 for details. The IRB strongly recommends either CITI training or in-person training. These training programs allow the IRB to access your training records. The IRB cannot access your training records if done via other Programs, which may result in a delay of IRB approval.

How can I minimize delays in the IRB review process?

Human subjects training for the PI and all Princeton research personnel must be completed. This is a one-time training requirement. The training can be from any source if the training directly addresses human subjects research. For example, training in conflicts of interest, biosafety, animal research, or responsible conduct of research work will not be recognized. Please see pages 5-6 of Princeton University IRB SOP 202 for details. The IRB strongly recommends either CITI training or in-person training. These training programs allow the IRB to access your training records. The IRB cannot access your training records if done via other Programs, which may result in a delay of IRB approval.

Use simple, direct language in the consent form that is targeted to your audience.

If the IRB asks for revisions, upload only the items that were revised. In other words, if we ask for revisions to the application, do not re-upload the consent form. If you re-upload a document that the IRB did not ask for revisions to, the IRB will need to re-review the document, which will delay the review process.

How do I submit my study?

You will submit the study using eRIA. Please see the eRIA WEBSITE for more information.

I submitted my study to the IRB. Can I start my study now?

No. You must not do human subjects research until you receive the IRB approval letter.

I received a letter from the IRB that states that my study was conditionally approved. Can I start my study now?

No. You must not do human subjects research until you receive the IRB approval letter.

When will my item be reviewed?

Submissions are reviewed within 5 business days of submission. The most common decisions are approve; approve pending revisions; or assignment to a convened Board (which occurs monthly, except for the summer). Please see the Meetings and Deadlinessection of our site for the meeting schedule. Note that only 1% of submissions require review by the convened Board. Even so, we encourage you to submit your item as soon as possible.

IRB Determinations

If my activity is human subjects research, is IRB approval required?

Yes. IRB approval is not optional or a "best practice." Note that Princeton IRB approval is required before implementation of the activity. The IRB will not grant approval after the human subjects research has been done.

I've reviewed your website and concluded that my activity is not human subjects research. Do I submit any forms to the IRB?

No. If you are confident the activity is not human subjects research , proceed with the activity. An IRB determination is not required.

I conducted an activity and would like to publish my findings. The journal is asking for an IRB determination. Can I obtain an IRB determination after the activity is done?

If the activity was not human subjects research, the IRB can provide a determination to that effect that you can provide to the journal. However, if the activity was human subjects research, the IRB will not grant approval after human subjects research has been done.

What if I'm unsure whether my activity is human subject research? Can I contact the IRB?

Absolutely. The IRB wants to continue to be a resource to the Princeton research community. Note that human research determinations are not made via phone or in person. If you would like a written determination, please e-mail a synopsis of the proposed activity (approximately 1 page) to the IRB. Please include the following in the synopsis:

What if I'm collaborating with a researcher from another institution or organization?

Your role in the human subjects research may engage Princeton University in the research. E-mail a synopsis of the proposed activity (2-3 paragraphs) to the IRB. Please include the following in the synopsis:

Study funding

Purpose

Study procedures. You will want to describe the overall study procedures and the procedures that the Princeton individual(s) will perform.

Any draft study measurements (survey, questionnaire, and interview guide). We will determine whether your role in the research requires Princeton IRB review.

Do I have to use the informed consent template?

We encourage you to use the informed consent form template. Since it's a template, you can modify it according to your study's needs. However, substantial variations may result in a delay of the review process.

Why isn't there an assent template?

The assent form should be an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. The explanation should include a discussion of any discomforts and inconveniences, in non-technical terms, the child may experience if she or he agrees to participate. Due to these variables, the investigator is in a better position to draft the assent form.

What are my obligations as an investigator?

I've heard about a new law that governs human subjects research. Where can I get more information?

The new law, called The Final Rule, is effective January 21, 2019. Information about the Final Rule will be posted on that date.

What if I want to modify my approved study?

All modifications must be approved by the IRB before implementation of the modification. If you want to change the protocol (conduct of the study) or any other aspect of the study (e.g., research personnel, consent form edits, recruitment changes, number of subjects, etc), please submit a modification request using eRIA. Please upload any new documents and any previously approved documents that are affected by the modification, e.g., initial review application that serves as the protocol; consent form; recruitment materials; survey, questionnaire, interview guide. After the IRB approves it, you can implement the change.

The expiration date of my study is approaching. Do I need to submit a continuing review?

Continuing review and re-approval of a research project at least annually is required so long as the project continues to involve human subjects. OHRP considers a research project to continue to involve human subjects as long as the investigators conducting the research continue to obtain:

Data about the subjects of the research through intervention or interaction with them; or

Collecting or receiving identifiable private information (including identifiable biological specimens) from any source (i.e., not already in the possession of the investigator);

Collecting identifiable private information by observing or recording private behavior without interacting or intervening with the human subjects; and

Using, studying, or analyzing identifiable private information (including identifiable biological specimens), even if the information was already in the possession of the investigator before the research begins. This includes using, studying, or analyzing any of the following:

Identifiable private information obtained by interacting or intervening with the human subjects;

Identifiable private information stored in documents, records, photographs, images, video recordings, or audio recordings already in the possession of the investigator before the research begins;

Identifiable private information obtained about an individual by interviewing other people (e.g., an individual’s healthcare provider or teacher);

Identifiable biological specimens provided to the investigators from any source; or

Identifiable biological specimens already in the possession of the investigator before the research begins.

A research project no longer involves human subjects once the investigators have finished obtaining data through interaction or intervention with subjects or obtaining identifiable private information about the subjects, which includes the using, studying, or analyzing identifiable private information. Once all such activities described in the IRB-approved protocol are finished, the research project no longer needs to undergo continuing review. For example, when the only remaining activity of a research project involves the analysis of aggregate data sets without individual subject identifiers, no further continuing review is necessary. At that point the IRB can formally close the IRB file for that project and advise the investigator of that action. Similarly, simply maintaining individually identifiable private information without using, studying, or analyzing such information is not human subjects research and thus does not require continuing review.

IRB approval for my study expired. What does this mean?

Once IRB approval expires, you must stop all research activities. This includes recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information.

I need to speak with someone about my IRB application. Is someone available and do I need an appointment?

You're welcome to call the IRB (609-258-1194) or stop by the IRB office at 87 Prospect Avenue, room 310. An IRB representative is almost always in the office. An appointment is not required.